Description of Event or Problem · 1
INFECTION TO THE RIGHT KNEE/METHICILLIN SENSITIVE STAPH AUREUS (MSSA) (B)(6) JOINT SWELLING]; RIGHT KNEE VERY PAINFUL [ARTHRALGIA]; RIGHT KNEE WARM TO TOUCH [JOINT WARMTH]; UNABLE TO STRAIGHTEN UP THE RIGHT KNEE [JOINT RANGE OF MOTION DECREASED]. CASE DESCRIPTION: THIS SERIOUS SPONTANEOUS DEVICE REPORT WAS RECEIVED FROM A NURSE IN THE UNITED STATES. A PATIENT, A (B)(6) MALE EXPERIENCED INFECTION OF THE RIGHT KNEE AND THE RIGHT KNEE WAS VERY SWOLLEN, VERY PAINFUL, WARM TO TOUCH, AND UNABLE TO STRAIGHTEN IT UP AFTER RECEIVING THE EUFLEXXA INTRA-ARTICULAR INJECTIONS (1% SODIUM HYALURONATE) ONCE A WEEK FOR THREE WEEKS TO BOTH KNEES FOR KNEE PAIN. LOT NUMBER : K10183A AND EXPIRATION DATE: 20 JULY 2015. IN 2012, 2013, AND 2014 THE PATIENT RECEIVED SERIES OF EUFLEXXA INJECTIONS WITHOUT ANY HISTORY OF ANY REACTIONS. ON (B)(6) 2015, THE MALE PATIENT INITIATED EUFLEXXA THERAPY AND RECEIVED HIS FIRST INTRA-ARTICULAR INJECTION. ON (B)(6), THE PATIENT RECEIVED HIS SECOND EUFLEXXA INJECTION. IN THE EVENING OF (B)(6) 2015, THE PATIENT STARTED TO EXPERIENCE RIGHT KNEE INFECTION, WAS VERY SWOLLEN, VERY PAINFUL, WARM TO TOUCH, AND WAS UNABLE TO STRAIGHTEN UP THE RIGHT KNEE. ON (B)(6) 2015, THE PATIENT WENT TO THE EMERGENCY ROOM AND ON THE SAME DAY, THE PATIENT UNDERWENT SURGERY TO THE RIGHT KNEE AND WAS DIAGNOSED WITH (B)(6) TO THE RIGHT KNEE. ON (B)(6) 2015, THE PATIENT UNDERWENT ANOTHER SURGERY FOR IRRIGATION AND DEBRIDEMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2015. AS PER REPORTING NURSE, THE PHYSICIAN STRONGLY FELT THAT THE REPORTED EVENT INFECTION TO THE RIGHT KNEE WAS RELATED TO EUFLEXXA. DUE TO THE EVENTS, EUFLEXXA INJECTION WAS DISCONTINUED. AT THE TIME OF REPORTING, THE PATIENT HAD NOT RECOVERED FROM THE REPORTED EVENTS. MEDICAL HISTORY WAS PROVIDED AND INCLUDED PRIOR HISTORY OF RECEIVING OTHER INJECTION (DRUG NAME UNKNOWN) TO THE KNEES IN 2009 AND 2010. CONCOMITANT MEDICATIONS WERE PROVIDED. SENDER COMMENT: REPORTER CAUSALITY: RELATED.